21 C.F.R. § 524.1195

Ivermectin otic suspension.

Last amended: 2016Year: 2026Length: 114 wordsSubsections: 3Official source

Cite as 21 C.F.R. § 524.1195 (2026)

(a) Specifications. Each tube contains 0.5 milliliter (mL) of a 0.01 percent suspension of ivermectin. (b) Sponsor. See No. 000010 in § 510.600(c) of this chapter. (c) Conditions of use —(1) Amount. Administer the contents of one 0.5-mL tube topically into each external ear canal. (2) Indications for use. For the treatment of adult ear mite ( Otodectes cynotis ) infestations in cats and kittens 4 weeks of age and older. Effectiveness against eggs and immature stages has not been proven. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [66 FR 7578, Jan. 24, 2001, as amended at 74 FR 26782, June 4, 2009]
Cross-references to the CFR
510.600
21 C.F.R. § 524.1195: Ivermectin otic suspension. | Justis AI